Job description
The Role:Moderna is seeking an Engineer III to join the mRNA Process Development team to support development, scale up, transfer and commercialization of drug substances based on mRNA and lipid nanoparticle delivery technologies.
Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The candidate will be focused on unit operations that are standard across the industry such as enzymatic reactions, normal and tangential flow filtration and chromatographic purification. The candidate will support commercial manufacturing processes and execute experiments to support deviation investigations and definition of appropriate process controls to increase process robustness.
Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using quality by design (QbD) and Design of Experiment (DoE) methods, and will collaborate through cross-functional matrix teams. The person in this role will have the opportunity to develop on-line analytics, process modelling and process investigation support. Results will be presented to broader groups allowing great exposure to CMC Strategy, Regulatory, MS&T, and Quality. Prior experience of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.
In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches. The position will be based out of Moderna’s Norwood facility.
Here’s What You’ll Do:
Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modeling
Define the process, the critical parameters, and the design space
Create high throughput and automated experimental setups
Lead experiments to confirm robust process performance across the control space
Characterize mRNA properties through collaboration with the analytical team
Prepare process descriptions, technical reports, and communicate findings internally and externally as appropriate
Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
Here’s What You’ll Bring to the Table:
BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related field
BS with 5-8 years, or MS with 2-5 years of relevant industry experience in bioprocess development
Hands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations
Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
Experience with analytics and biophysical characterization of nanoparticles is a plus
Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plus
Knowledge of nucleic acid chemistry, lipid chemistry, and biology is a plus
Ability to thrive in a diverse and fast paced environment
Excellent written and verbal communication skills
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-KP1
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